BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGANOX METRA

    MDR report key: 20295510 · Received September 24, 2024

    Report

    Report Number
    3011560054-2024-00088
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 27, 2024
    Report Date
    March 14, 2025
    Manufacturer
    ORGANOX LIMITED
    Product Code
    QQK
    UDI-DI
    5060462240005
    PMA / PMN Number
    P200035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYRINGE DRIVER HAS UNDERGONE A FULL VISUAL INSPECTION. THERE WERE MARKS OF CONTAMINATION ON THE ASSEMBLY OVERALL, THESE MARKS ARE MOST LIKELY TO BE FROM THE NUTRIENTS IN THE SYRINGES AS THEY ARE PRIMED PRIOR TO CONNECTION WITH THE DISPOSABLE SET. THESE DROPLETS ON THE ASSEMBLY CONTAMINATED THE LINEAR GUIDES AND, MOST LIKELY, CAUSED THE BEARINGS TO FAIL. THE UNIT WAS CLEANED. THERE ARE MARKS OF FLUIDS CONTAMINATING THE RIGHT LINEAR SHAFT, THE FLUIDS ENTERING THE BEARING HOUSING WOULD CAUSE THE BEARINGS TO FAIL AS WELL. VISIBLE MARKS OF STICKY FLUID CONTAMINATING THE ASSEMBLY, AND THE LINEAR SHAFTS ARE CAUSING THE BEARINGS TO FAIL AND NOT PERFORM AS EXPECTED. THE FAILURE MODE WAS NOTED TO BE THE SEALING OF THE BEARING ON THE RIGHT LINEAR SHAFT BROKE AND ALLOWED THE BEARING SEAL TO LEAVE THE BEARING HOUSING. THE ROOT CAUSE OF THE ISSUE IS ATTRIBUTED TO FAILURE OF THE DEVICE USER TO ADEQUATELY CLEAN THE DEVICE.

    Additional Manufacturer Narrative · 0

    A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. DURING INSPECTION OF THE SYRINGE DRIVER, THE SE OBSERVED THAT THE GASKET AND BALL BEARINGS ON THE RIGHT SIDE SHAFT HAD COME OFF. THEREFORE, THEY PROCEEDED TO REPLACE THE SYRINGE DRIVER AND COMPLETED OVERNIGHT TESTING. AFTERWARDS, THE SYSTEM OPERATED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED THAT THEY HAD AN ISSUE WITH THE DEVICE WHILE THEY WERE PREPARING TO PUMP A LIVER. DURING THE PREPARATION PHASE, THEY NOTICED THAT THE SYRINGE DRIVER LOCKING IN MECHANISM WAS STUCK. THEY SUCCESSFULLY DISENGAGED THE LOCK AND THEN NOTICED THAT A GASKET AND BALL BEARING HAD FALLEN OUT ON ONE OF THE SIDES. THEREFORE, THE DU PROCEEDED TO MOVE ALL THEIR PREPARATION EFFORTS TO ANOTHER DEVICE.

    Description of Event or Problem · 0

    THE DEVICE USER (DU) REPORTED THAT THEY HAD AN ISSUE WITH THE DEVICE WHILE THEY WERE PREPARING TO PUMP A LIVER. DURING THE PREPARATION PHASE, THEY NOTICED THAT THE SYRINGE DRIVER LOCKING IN MECHANISM WAS STUCK. THEY SUCCESSFULLY DISENGAGED THE LOCK AND THEN NOTICED THAT A GASKET AND BALL BEARING HAD FALLEN OUT ON ONE OF THE SIDES. THEREFORE, THE DU PROCEEDED TO MOVE ALL THEIR PREPARATION EFFORTS TO ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291414 ORGANOX METRA NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR QQK ORGANOX LIMITED 5060462240005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown